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Vacancy Details


Software Quality Engineer - Galway - 96758

Contract Type: Permanent
Location: Galway
Date: 28/02/2019
Job Reference: 96758
Contact Name: Karl Lippett
Contact Email:

Job Description

Software Quality Engineer - Galway - 96758
Contact: Karl Lippett
Telephone: 086 1070950

Software Quality Engineer
Our client, a medical device company in Galway is currently looking to recruit a Software Quality Engineer for their site.

  • Lead Quality and Compliance activities in relation to Software projects.
  • Support, guide, and monitor projects, to ensure that approved software development standards, processes, and procedures are adhered to, as well as make recommendations on the adoption of industry best-practices.
  • Ensure that company processes, SOPs and forms for computer systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
  • Collaborate with project teams to set determine the validation strategy and plan for execution.
  • Quality reviewer on all computer systems validation documentation and system supporting documentation.
  • Author computer system validation documentation; test scripts, protocols, reports,
  • Pre and post-execution approval for all validation test scripts
  • Review and approval of deviations arising from computer system validation activities. Provide input into addressing deviations and approval of deviation outcome.

Duties specific to ERP implementation project;
  • Responsible for the accuracy of completeness of static and dynamic data relating to QA/RA functionality.
  • Responsible for determining system parameters & Code Tables relating to QA/RA functionality.
  • Responsible for preparation of specifications, implementation and testing of ERP system-generated documentation related to QA/RA functionality, e.g. labels, forms, reports.
  • Responsible for definition and control of audit logs and electronic signatures.
  • Test and where applicable design and implement enhancements to software system in conjunction with the software vendor to ensure the business needs are met.
  • Author computer system training guides and operating instructions for QA/RA functionality.
  • Work with QA/RA staff to implement changes to business processes and related SOPs to accommodate ERP functionality.
  • Author new SOPs and Work Instructions relating to new ERP functionality.
  • Provide training to QA/RA staff in the use of system functionality.

Specific Requirements
  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate effectively with all levels of the company.
  • Ability to meet deadlines and follow through on assigned deliverables.
  • Attention to detail.
  • Proficiency in use of desktop software applications such as MS Office

Education / Experience
  • BSc. degree in Computer Science or Quality Assurance, or equivalent industrial experience with Computer Software Validation within the medical device industry, of which at least two years must be within a quality assurance or related role.
  • Experience of implementation and validation ERP business systems is desired.
  • Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Part11 and Part 820.
  • Familiarity with GAMP5 Guideline for ‘Risk-Based approach to GxP Compliant Computerised systems.
  • Familiarity with Agile practices for software implementation and product development, particularly SCRUM.

For further information on this Software Quality Engineer role in Galway please contact Karl Lippett on 086 1070950 /

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Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
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Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
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Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

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Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

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Ingersoll Rand – Thermo King

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